(28 days)
The Braun PrecisionSensor Pro (BP2590) wrist blood pressure monitor is indicated for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a professional environment. Use may be initiated as part of a hypertension screening, monitoring, and/or management program supervised by a healthcare provider.
The PrecisionSensor Pro is a non-invasive wrist blood pressure monitor that measures and displays systolic and diastolic blood pressure, and pulse rate. The values are ascertained by the oscillometric method.
Here's a breakdown of the acceptance criteria and study information for the Braun PrecisionSensor™ Pro (BP2590) wrist blood pressure monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for blood pressure and pulse rate accuracy. It primarily focuses on the device's substantial equivalence to a predicate device and its intended use. However, the implicit acceptance criterion is that the device performs at least as well as the predicate device and is suitable for its intended professional use.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Blood Pressure Accuracy | Comparable to Braun PrecisionSensor™ (BP2000 Series) wrist blood pressure monitor | The document states "The basic design, intended use, and indications for use... are similar. The fundamental scientific technology of the modified device has not changed from that of the predicate device." This implies that the accuracy performance is expected to be as good as the predicate. |
| Pulse Rate Accuracy | Comparable to Braun PrecisionSensor™ (BP2000 Series) wrist blood pressure monitor | Same as above. |
| Non-invasive Measurement | Device measures non-invasively using the oscillometric method | Explicitly stated in the "Device Description." |
| Professional Environment Suitability | Reconfigured display and memory, higher grade of Velcro for cuff closure | These modifications were made to "make it robust for use in a professional environment." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not include information about a specific clinical test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary primarily asserts substantial equivalence based on modifications to an existing device rather than presenting new clinical study data for device accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. As there's no detailed clinical study presented, there's no mention of ground truth establishment by experts for a test set.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance. This device is a blood pressure monitor, not an AI-powered diagnostic imaging tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not describe a standalone performance study for an algorithm. The device itself is a standalone blood pressure monitor; its performance is inherent to its design and oscillometric method.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any formal clinical validation study. Given the nature of a blood pressure monitor and the 510(k) summary's focus on substantial equivalence, it's highly probable that if a validation study were conducted, it would involve comparison to a gold standard like auscultatory measurements by trained professionals or a thoroughly validated sphygmomanometer. However, this is an inference and not explicitly stated.
8. The Sample Size for the Training Set
There is no mention of a training set sample size in the provided document. As a conventional medical device (blood pressure monitor) relying on established oscillometric principles, it's unlikely to have a "training set" in the context of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set or machine learning components.
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UUL 2 7 2001
510(k) Summary
Special 510(k) Summary of Safety and Effectiveness
Company information
Braun GmbH Frankfurter Strasse 145 D-61476 Kronberg Germany
Device Identification
Trade Name - Braun PrecisionSensor™ Pro (BP2590) Classification Name - Wrist blood pressure monitor Classification - Class II Product Code - 74 DXN
Predicate Device
Braun PrecisionSensor™ (BP2000 Series) wrist blood pressure monitor.
Device Description
The PrecisionSensor Pro is a non-invasive wrist blood pressure monitor that measures and displays systolic and diastolic blood pressure, and pulse rate. The values are ascertained by the oscillometric method.
Intended Use
The PrecisionSensor™ Pro (BP2590) is intended to be used for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults in a professional environment.
Intended Patient Population
Adults are the intended patient population to use this device.
09 001
KO12035
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Intended Environment of Use
The intended environment of use is in professional medical environments (e.g., The intonous offices, clinics, nursing homes, hospitals) where blood pressure may be measured.
Indications for Use
The Braun PrecisionSensor™ Pro (BP2590) wrist blood pressure monitor is indicated for use for the noninvasive measurement of blood pressure (systolic indidiastolic) and pulse rate in adults, in a professional environment. Use may and diaololio, and part of a hypertension screening, monitoring, and/or management program supervised by a healthcare provider.
Comparison of the Braun PrecisionSensor™ Pro (BP2590) wrist blood onmanson of the Braun PrecisionSensor™ (BP2000 Series) wrist blood pressure monitor.
The basic design, intended use, and indications for use of the Braun PrecisionSensor Pro (BP2590) and the Braun PrecisionSensor™ (BP2000 Series) are similar . The fundamental scientific technology of the modified device has not changed from that of the predicate device.
The primary changes in the modified design of the Braun PrecisionSensor Pro (BP 2590) consist of reconfiguring the display and memory, and using a higher grade of Velcro for the cuff closure to make it robust for use in a professional environment while the predicate device, the Braun PrecisionSensor (BP2000 Series), is indicated for use in a home environment. To visually distinguish the oofessional use blood pressure monitor from the home use monitor, the color of the Velcro cuff was changed from blue to black and the monitor housing was changed from blue or white to silver.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird-like figure with three wing-like extensions.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2001
Braun GmbH c/o Mr. Fred Schlador Regulatory Resources, LLC 6183 Paseo Del Norte, Suite 150 Carlsbad, CA 92009
Re: K012035
Trade Name: Braun PrecisionSensor™ Pro, Model BP 2590 Regulatory Number: 21 CFR 870.1130 Regulatory Class: II (two) Product Code: 74 DXN Dated: June 28, 2001 Received: June 29, 2001
Dear Mr. Schlador:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Mr. Fred Schaldor
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonification. The I Drice results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific active ro first diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in 10 millionally, for questions on the promotion and advertising of your device, (201) 594-46. Truchionally, 201 quest at (301) 594-4639、Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsive at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
DaKi Teth
L. Lee F. Dill, III
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K012035
Device Name:
PrecisionSensor™ pro (BP2590) Wrist Blood Pressure Monitor
Indications for Use:
The Braun PrecisionSensor Pro (BP2590) wrist blood pressure monitor is The Braun Procloionsonsoninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a professional use (Systollo and diacters) ane initiated as part of a hypertension screening, environinent: 600 may agement program supervised by a healthcare provider.
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Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109 OR
Over the Counter √
Division of Cardiovascular & Respiratory Devices
510(k) Number K012035
03 002
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).